August 2019—SpeeDx Pty. announced that the FDA has granted breakthrough device designation for its ResistancePlus GC, a molecular test providing ciprofloxacin susceptibility and resistance information to effectively treat N. gonorrhoeae. It is CE marked and cleared by the Therapeutic Goods Association for use in Europe, Australia, and New Zealand. It detects N. gonorrhoeae and sequences in the gyrA gene of the bacteria associated with susceptibility or resistance to ciprofloxacin.
SpeeDx is conducting multisite clinical trials for the ResistancePlus MG test (not currently available for sale in the United States). The molecular test detects Mycoplasma genitalium along with genetic markers linked to antibiotic resistance.
SpeeDx, 512-200-6918